COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Electro Lube NXT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GATED MIBI 3-D EJECTION FRACTION PROCESSING

FDA 510(k)

FDA Class 2 ·Radiology

COMPEL XTR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Mini ONE Enteral Extension Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED

FDA 510(k)

FDA Class 2 ·Hematology

RESTORE

FDA 510(k)

FDA Class 2 ·Ophthalmic

WRAPPEL T

FDA 510(k)

FDA Class 2 ·General Hospital

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COMFORT + LIFT

FDA 510(k)

FDA Class 2 ·Physical Medicine

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

MIDMARK M9 ULTRACLAVE STEAM STERILIZER

FDA 510(k)

FDA Class 2 ·General Hospital

MAYFIELD ADULT DISPOSABLE SKULL PIN

FDA 510(k)

FDA Class 2 ·Neurology

AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VERSABOARD, MODEL 7040

FDA 510(k)

FDA Class 2 ·Radiology

BIOPSY TRAY I & II

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery